# K182501: Hair Laser Headband

- Pathway: 510(k) (Special)
- Applicant: Pulsaderm, LLC
- Decided: Oct 26, 2018 after 44 days
- Product code: OAP (Laser, Comb, Hair)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K001179 (2000). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160728: NutraStim Hair Laser Helmet, Nutra Luxe MD, LLC (2016) Summary page 4.

## Indications for use
The Laser Headband is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood Hamilton Classifications of 11a to V patterns of hair loss and treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) Scale 1-4, 11-1, 11-2, or frontal, both with Fitzpatrick Skin Types I to IV.

Source page: https://510kreport.com/device/K182501
Methodology: https://510kreport.com/methodology